There is an industrywide drive toward a unified clinical operating
model, according to the Veeva
2017 Unified Clinical Operations Survey,one of theindustry’s
largest annual surveys of clinical operations professionals. The new
research from Veeva
Systems (NYSE: VEEV) reveals that nearly all respondents cite the
need to unify their clinical applications, including EDC, CTMS, and
eTMF. More than 60% say faster study execution and improved study
quality are the top drivers toward a unified clinical model, which is
characterized by end-to-end processes and systems, visibility across the
clinical lifecycle, and modern information systems.

Streamlining Clinical Systems and Processes

Many of the challenges sponsors face today in managing clinical trials
stem from the disparate nature of their processes and
systems. Respondents use an average of four applications to manage their
clinical studies and more than one-third use at least five applications.
The most commonly used applications are EDC and CTMS (81% and 59%
respectively).

Nearly all survey respondents have at least one major challenge with
their clinical applications and the top two challenges – integrating
multiple applications (69%) and reporting across applications (61%) –
are a direct result of system silos. Half of sponsors say issues
integrating their EDC or eTMF applications with CTMS limits their
organization’s ability to improve clinical operations.

Companies also say their current clinical systems are hard to use (46%)
and lack the ability to support collaboration (33%). Usability and
accessibility issues likely contribute to the difficulties one-third say
they face with data being tracked outside of their clinical systems.

Half of respondents also cite better study visibility as one of the most
important drivers for unifying the clinical landscape, especially given
the challenges most have with reporting across multiple applications.
The ability for companies to collect and leverage operational data
throughout the clinical lifecycle has a direct impact on improving
efficiency and execution in clinical operations.

Transitioning to Modern Information Systems

Companies have started on a path to unified clinical enabled, in part,
by the introduction of newer, more advanced applications and platforms.
Trial master file (TMF) management is one of the first areas to
experience rapid transformation. Over the past four years there has been
a major shift as one in three (31%) sponsors now use an advanced eTMF
application, more than double the number in 2014.

The transition toward modern, purpose-built eTMF applications and
‘active’ TMF management – the ability to manage information and
processes in real-time as the TMF is being generated – is delivering
greater benefits than ‘passive’ first-generation local file systems and
cloud file shares. More than three-quarters (79%) of sponsors report
improvements in inspection readiness after implementing an active eTMF
application. Modern eTMF applications also significantly improve
activities key to unifying clinical operations and better managing the
growing volume and complexity of clinical trials, including visibility
into key study performance metrics.

There is also a significant shift underway in clinical trial management
as life sciences companies expect to increase their CTMS investments by
almost 15% each year through 2020. This is being driven by rising demand
for data and site collection solutions and the availability of
next-generation CTMS applications.1 This is not surprising,
given that nearly all sponsors (98%) say challenges with their current
CTMS applications are limiting their ability to improve clinical
operations. Among their biggest issues are their inability to fully
support resource management (77%), study and site feasibility (76%),
financial management (75%), and issue/task management (73%).

“The industry’s transition toward a unified clinical environment is
being driven by its need to address the silos legacy systems have
created,” said Jennifer Goldsmith, senior vice president of Veeva Vault.
“Life sciences companies are taking steps to streamline their end-to-end
processes and systems with modern applications so they can execute
faster and improve visibility across their study portfolios.”

The Veeva 2017 Unified Clinical Operations Survey examines the
life sciences industry’s progress toward a unified clinical environment
by gathering the experiences and opinions of 300 clinical operations
professionals from around the globe. Evolved from the annual Veeva
Paperless TMF Survey, this research examines the drivers, barriers,
and benefits of a unified clinical operating model and tracks the move
to streamline clinical systems and processes.

In related news
today, Veeva announced that Veeva
Vault CTMS is gaining momentum as customers drive toward a unified
clinical operating model. Within just two months of the product’s
release, five customers, including a top 50 global pharmaceutical
company, are implementing Veeva Vault CTMS. In more news,
Regeneron Pharmaceuticals (NASDAQ:REGN), is standardizing on Veeva
Vault Submissions and Veeva
Vault eTMF to further streamline clinical and regulatory operations.

Veeva Systems Inc. is a leader in cloud-based software for the global
life sciences industry. Committed to innovation, product excellence, and
customer success, Veeva has more than 525 customers, ranging from the
world's largest pharmaceutical companies to emerging biotechs. Veeva is
headquartered in the San Francisco Bay Area, with offices in Europe,
Asia, and Latin America. For more information, visit www.veeva.com/eu.

Forward-looking Statements

This release contains forward-looking statements, including the market
demand for and acceptance of Veeva’s products and services, the results
from use of Veeva’s products and services, and general business
conditions, particularly in the life sciences industry. Any
forward-looking statements contained in this press release are based
upon Veeva’s historical performance and its current plans, estimates,
and expectations, and are not a representation that such plans,
estimates, or expectations will be achieved. These forward-looking
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and Veeva disclaims any obligation to update the forward-looking
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Condition and Results of Operations” in the company’s filing on Form
10-Q for the period ended April 30, 2017. This is available on the
company’s website at veeva.com
under the Investors section and on the SEC’s website at sec.gov.
Further information on potential risks that could affect actual results
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